在泌尿瘤学随机对照试验中使用安慰剂
Zijing Cheng1,2, Timothy Campbell1, Trevor C Hunt1
1Department of Urology, University of Rochester Medical Center, Rochester, New York.
Urology practice
|August 28, 2024
概括
在泌尿瘤学试验中,活性治疗比安慰剂引起的不良事件 (AE) 和严重不良事件 (SAE) 更多. 这表明,在瘤学随机对照试验 (RCT) 中的盲目化通常会受到损害,影响研究的有效性.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
背景情况:
- 在瘤学随机对照试验 (RCT) 中,安慰剂的伦理使用受到争论.
- 使用安慰剂可能会引入偏见,因为可能会从毒性概况中揭开潜在的盲目.
- 在泌尿瘤学RCT中研究安慰剂控制对于试验完整性至关重要.
研究的目的:
- 评估安慰剂使用对泌尿瘤学RCT失明的影响.
- 为了确定不良事件 (AE) 和瘤结局的差异是否会影响失明.
- 假设大多数安慰剂对照试验实际上是没有盲目的.
主要方法:
- 从ClinicalTrials.gov (2014-2024) 中使用安慰剂识别出尿道瘤学RCT.
- 包括前列腺癌,膀/尿道癌和癌的试验.
- 在安慰剂和活跃臂之间比较了受试者不完全,死亡率,AE和严重AE (SAE) 率.
主要成果:
- 分析了66个安慰剂臂 (12,918名受试者) 和81个活跃臂 (16,098名受试者) 的60项研究.
- 没有观察到对象不完成率的显著差异.
- 与安慰剂组相比,活跃组的SAE (18/24域) 和AE (13/24域) 发生率明显更高.
结论:
- 泌尿瘤学RCT中的活性治疗手臂与安慰剂手臂相比,与更高的AE和SAE率有关.
- 这些发现表明,在瘤学RCT中,真正的失明可能是无法实现的.
- 结果将为未来的临床试验设计提供有关安慰剂对照的挑战的信息.
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